A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy
9 juli 2014 uppdaterad av: Vertex Pharmaceuticals Incorporated
A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response
To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment.
Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
117
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Creteil, Frankrike
- Hospital Henri Mondor
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Lyon, Frankrike
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Nice, Frankrike
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Paris, Frankrike
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Pessac, Frankrike
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Vandoeuvre, Frankrike
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Alabama
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Birmingham, Alabama, Förenta staterna
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California
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Los Angeles, California, Förenta staterna
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San Diego, California, Förenta staterna
- Kaiser Permanente Internal Medicine
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San Francisco, California, Förenta staterna
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Colorado
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Denver, Colorado, Förenta staterna
- University of Colorado Health Sciences Center
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Englewood, Colorado, Förenta staterna
- South Denver Gastroenterology
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Florida
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Gainesville, Florida, Förenta staterna
- University of Florida
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Jacksonville, Florida, Förenta staterna
- Borland-Groover Clinic
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Jacksonville, Florida, Förenta staterna
- Mayo Clinic Jacksonville
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Miami, Florida, Förenta staterna
- University of Miami Center for Liver Diseases
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Sarasota, Florida, Förenta staterna
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Georgia
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Atlanta, Georgia, Förenta staterna
- Atlanta Gastroenterology Associates
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Illinois
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Chicago, Illinois, Förenta staterna
- University of Chicago
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Indiana
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Indianapolis, Indiana, Förenta staterna
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna
- Digestive and Liver Disease Clinic
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Maine
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Portland, Maine, Förenta staterna
- Virology Treatment Center, Maine Medical Center
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Maryland
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Baltimore, Maryland, Förenta staterna
- Johns Hopkins University
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Massachusetts
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Boston, Massachusetts, Förenta staterna
- Beth Israel Deaconess Medical Center
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Worcester, Massachusetts, Förenta staterna
- University of Massachusetts Memorial Medical Center
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Michigan
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Detroit, Michigan, Förenta staterna
- Henry Ford Hospital
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Missouri
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St Louis, Missouri, Förenta staterna
- St Louis University
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Nebraska
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Omaha, Nebraska, Förenta staterna
- The Nebraska Medical Center
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New Mexico
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Albuquerque, New Mexico, Förenta staterna
- University of New Mexico
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New York
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Manhasset, New York, Förenta staterna
- North Shore University Hospital
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New York, New York, Förenta staterna
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North Carolina
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Durham, North Carolina, Förenta staterna
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, Förenta staterna
- University of Cincinnati
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Cleveland, Ohio, Förenta staterna
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Pennsylvania
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Hershey, Pennsylvania, Förenta staterna
- Penn State Hershey Medical Center
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Pittsburgh, Pennsylvania, Förenta staterna
- University of Pittsburgh Medical Center
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South Carolina
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Columbia, South Carolina, Förenta staterna
- Columbia Gastroenterology Associates, PA
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Tennessee
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Germantown, Tennessee, Förenta staterna
- Memphis Gastroenterology Group
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Texas
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Dallas, Texas, Förenta staterna
- Liver Institute at Methodist Dallas
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Houston, Texas, Förenta staterna
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San Antonio, Texas, Förenta staterna
- Alamo Medical Research
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Virginia
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Annandale, Virginia, Förenta staterna
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Charlottesville, Virginia, Förenta staterna
- University of Virginia Health Systems
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Fairfax, Virginia, Förenta staterna
- Metropolitan Research
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Richmond, Virginia, Förenta staterna
- McGuire DVAMC
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Alberta
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Calgary, Alberta, Kanada
- University of Calgary Medical Clinic
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Edmonton, Alberta, Kanada
- University of Alberta
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British Columbia
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Vancouver, British Columbia, Kanada
- University of British Columbia Vancouver General Hospital
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Manitoba
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Winnipeg, Manitoba, Kanada
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Ontario
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Toronto, Ontario, Kanada
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Amsterdam, Nederländerna
- Academic Medical Center
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Leiden, Nederländerna
- Leiden University Medical Center
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Rotterdam, Nederländerna
- Erasmus MC Medical Center
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Santurce, Puerto Rico
- Fundacion de Investigation de Diego
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London, Storbritannien
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Berlin, Tyskland
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Bonn, Tyskland
- Universitätsklinikum Bonn
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Cologne, Tyskland
- University of Cologne
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Dusseldorf, Tyskland, 40225
- Uniklinik Duesseldorf
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Frankfurt, Tyskland
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Hannover, Tyskland
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Vienna, Österrike
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
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Läsplatta
Läsplatta
Andra namn:
Solution for Injection
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Experimentell: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
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Läsplatta
Läsplatta
Andra namn:
Solution for Injection
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Experimentell: Other
Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group.
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Läsplatta
Läsplatta
Andra namn:
Solution for Injection
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment
Tidsram: 24 weeks after the completion of treatment (up to Week 72)
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The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay.
The lower limit of detection was 10 international units per milliliter (IU/mL).
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24 weeks after the completion of treatment (up to Week 72)
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Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: Baseline through Week 48
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AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not.
An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug.
SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.
"Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
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Baseline through Week 48
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of Prior Relapsers With Undetectable HCV RNA
Tidsram: 24 weeks after the completion of treatment (up to Week 72)
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Prior relapsers: subjects who had undetectable HCV RNA at the end of treatment in parent study but reverted to detectable levels of HCV RNA after stopping treatment in parent study were categorized as prior relapsers.
Percentage of prior relapsers with undetectable HCV RNA 24 weeks after the completion of treatment in this study were presented.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay.
The lower limit of detection was 10 international units per milliliter (IU/mL).
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24 weeks after the completion of treatment (up to Week 72)
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Percentage of Subjects With End of Treatment Response
Tidsram: End of treatment (up to Week 48)
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Subjects were considered to have an end of treatment response if they completed the assigned treatment regimen and had undetectable HCV RNA at end of treatment or prematurely discontinued the assigned treatment regimen and had undetectable HCV RNA at the time of discontinuation.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay.
The lower limit of detection was 10 international units per milliliter (IU/mL).
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End of treatment (up to Week 48)
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Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment
Tidsram: 48 weeks after completion of treatment (up to Week 96)
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The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay.
The lower limit of detection was 10 international units per milliliter (IU/mL).
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48 weeks after completion of treatment (up to Week 96)
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Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response
Tidsram: Baseline up to Week 72
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Cross tabulation of number of subjects with eRVR/SVR status in present study was presented with respect to prior response status of subjects in parent studies.
eRVR=undetectable HCV RNA at Week 4 and Week 12, SVR=undetectable HCV RNA at end of treatment (EOT) and at 24 weeks after last dose of study treatment without any confirmed detectable HCV RNA in between.
Prior response=subjects were categorized into following categories based on their viral response in the parent study: Null Response (less than [<] 1-log10 decrease in HCV RNA at Week 4 or <2-log10 decrease in HCV RNA at Week 12), Partial Response (greater than [>] 2-log10 decrease in HCV RNA at Week 12, but detectable HCV RNA at Week 24), Viral Breakthrough (detectable HCV RNA during treatment after achieving undetectable HCV RNA), Relapse (undetectable HCV RNA at EOT but detectable HCV RNA during viral follow-up).
Plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay; lower limit of detection=10 IU/mL.
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Baseline up to Week 72
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Studierektor: Nathalie Adda, MD, Vertex Pharmaceuticals Incorporated
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2007
Primärt slutförande (Faktisk)
1 februari 2010
Avslutad studie (Faktisk)
1 februari 2010
Studieregistreringsdatum
Först inskickad
25 september 2007
Först inskickad som uppfyllde QC-kriterierna
25 september 2007
Första postat (Uppskatta)
26 september 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
5 augusti 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 juli 2014
Senast verifierad
1 juli 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Blodburna infektioner
- Smittsamma sjukdomar
- Leversjukdomar
- Flaviviridae-infektioner
- Hepatit, Viral, Human
- Enterovirusinfektioner
- Picornaviridae-infektioner
- Hepatit
- Hepatit A
- Hepatit C
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Antimetaboliter
- Antineoplastiska medel
- Immunologiska faktorer
- Interferoner
- Interferon-alfa
- Ribavirin
- Peginterferon alfa-2a
- Interferon alfa-2
Andra studie-ID-nummer
- VX06-950-107
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .